510(k) · Cleared
ClearedNihon Kohden CO2 Sensor Kit, Model TG-970P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Mar 2, 2009 as substantially equivalent to K040875 (Nihon Kohden America, Inc., 2004) after a 101-day review. Its family tree reaches back 4 generations to 1993. 3 later devices descend from it.
- Decided
- Mar 2, 2009
- Review
- 101 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K915494 (1993). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK915494 Nellcor Stat-Cap Airway CO2 Indicator, Model N-60Nellcor, Inc. · 1993
- 3 generations backK964305 Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with AccessoriesNihon Kohden America, Inc. · 1997
- 2 generations backK990063 Nihon Kohden TG-901T CO2 Sensor Kit with AccessoriesNihon Kohden America, Inc. · 1999
- 1 generation backK040875 Cap-One, Model TG-920PNihon Kohden America, Inc. · 2004
- This deviceK083456 Nihon Kohden CO2 Sensor Kit, Model TG-970PNihon Kohden America, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK122214 TG-970P Sensor Kit W/ New Airway Adapter (YG-213T)Nihon Kohden Corp. · 2013
- Descendant · cites it directly · 0 of its ownK243956 TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK161860 TG-970P CO2 Sensor KitNihon Kohden Corporation · 2017
Most influential descendants
Showing 3 of 3 · See all- K122214TG-970P Sensor Kit W/ New Airway Adapter (YG-213T)Nihon Kohden Corp. · 2013 · cites it directly1descendant
- K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden Corporation · 2025 · cites it directly0descendants
- K161860TG-970P CO2 Sensor KitNihon Kohden Corporation · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915494 | Nellcor Stat-Cap Airway CO2 Indicator, Model N-60 | Nellcor, Inc. | 1993 | — |
| −3 | K964305 | Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with Accessories | Nihon Kohden America, Inc. | 1997 | — |
| −2 | K990063 | Nihon Kohden TG-901T CO2 Sensor Kit with Accessories | Nihon Kohden America, Inc. | 1999 | — |
| −1 | K040875 | Cap-One, Model TG-920P | Nihon Kohden America, Inc. | 2004 | — |
| 0 (this device) | K083456 | Nihon Kohden CO2 Sensor Kit, Model TG-970P | Nihon Kohden America, Inc. | 2009 | — |
| +1 | K122214 | TG-970P Sensor Kit W/ New Airway Adapter (YG-213T) | Nihon Kohden Corp. | 2013 | — |
| +1 | K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | Nihon Kohden Corporation | 2025 | — |
| +2 | K161860 | TG-970P CO2 Sensor Kit | Nihon Kohden Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CCK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040875 | Cap-One, Model TG-920PSummary page 1…Part 868.1400 "Analyzer, Gas, Carbon dioxide, Gaseous-phase" as per part 73 CCK. Legally Marketed Predicate Device: Nihon Kohden TG-920P CO 2 Sensor Kit as per 5 10(k) K040875 commercial distribution certification dated October 15, 2004. Intended Use: The Nihon Kohden TG-970P Series CO 2 Sensor Kit is i… | 2004 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K122214 (Nihon Kohden Corp., 2013) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K040875.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
What is it indicated for?
The Nihon Kohden TG-970P Series CO 2 Sensor Kit is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. Along with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083456 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083456: Nihon Kohden CO2 Sensor Kit, Model TG-970P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083456
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026